Soft tissue repair method

ABSTRACT

The present disclosure relates to an instrument and method of manipulating soft tissue during a soft tissue repair procedure. The instrument and related method may include use of a handle and a shaft coupled to the handle, the shaft including a proximal portion and a distal portion, wherein the distal portion of the shaft comprises a tip including at least two prongs and a channel located between the prongs.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.12/725,686, filed Mar. 17, 2010, which claims priority to U.S.Provisional Patent Application No. 61/161,124, filed Mar. 18, 2009, andis related to U.S. patent application Ser. No. 14/642,337, filed on Mar.9, 2015, which is a divisional of U.S. patent application Ser. No.12/725,686; the disclosures of all of which are incorporated byreference herein in their entirety.

BACKGROUND Field of Technology

The present disclosure relates to a device and method for manipulatingsoft tissue during a soft tissue repair procedure.

Related Art

During repair of soft tissue, such as biceps tenodesis repair, thebiceps tendon is placed and temporarily secured in a prepared hole inthe humerus prior to final fixation of the tendon via a fixation device,such as an interference screw. Devices that would accomplish thistemporary placement and fixation are needed.

SUMMARY

In one aspect, the present disclosure relates to an instrument formanipulating soft tissue during a soft tissue repair procedure. Theinstrument includes a handle; and a shaft coupled to the handle, theshaft including a proximal portion and a distal portion, wherein thedistal portion of the shaft comprises a tip including at least twoprongs and a channel located between the prongs. In an embodiment, theinstrument is cannulated. In another embodiment, the distal portionincludes marks, the marks representing a measured distance from an endof at least one of the prongs to the marks. In yet another embodiment,an outer diameter of the tip is between about 4.5 mm to about 5.5 mm.

In another aspect, the present disclosure relates to a method of tissuerepair. The method includes creating a hole in bone; placing the softtissue over the hole; providing a cannulated instrument for insertingthe soft tissue into the hole, the instrument including a handle and ashaft coupled to the handle, the shaft including a proximal portion anda distal portion, wherein the distal portion includes a tip including atleast two prongs and a channel located between the prongs; inserting thesoft tissue into the hole via use of the instrument, wherein the softtissue is housed within the channel; and inserting a fixation deviceinto the hole to fix the soft tissue to the bone. In an embodiment, themethod further includes inserting a guide assembly through thecannulation of the instrument and into the bone prior to inserting thefixation device into the hole, the guide assembly comprising a guidewire and a vice coupled to the guide wire, the guide assembly insertedthrough the cannulation until a bottom portion of the vice engages withthe handle. In yet another embodiment, the method further includesinserting the fixation device into the hole via use of the guide wire.

In a further aspect, the present disclosure relates to a soft tissuemanipulator assembly. The manipulator assembly includes a soft tissuemanipulator instrument having a handle, a shaft coupled to the handle, atip coupled to the shaft, and a cannulation extending an entire lengthof the instrument; and a guide assembly disposed within the cannulation,the assembly comprising a guide wire and a vice coupled to the guidewire, the vice including a bottom portion and a top portion, the bottomportion in engagement with the handle.

In yet a further aspect, the present disclosure relates to a kit. Thekit includes a soft tissue manipulator instrument including a handle, ashaft coupled to the handle, and a tip coupled to the shaft; a guidewire; a vice including a top portion and a bottom portion, the bottomportion having a channel and a hole extending perpendicular to thechannel; and a fixation device. In an embodiment, the kit furtherincludes a drill bit; a reamer; and a driver.

Embodiments of the invention may include a method of attaching a bicepstendon to a humerus. Methods may include creating a hole in the humerusof a first diameter; severing a proximal end of the biceps tendon;pushing a portion of the biceps tendon into the hole with an instrumentthat captures the biceps tendon at a distal end of the instrument;inserting a distal portion of a guide wire though the biceps tendon andinto humerus in the hole in the humerus; and inserting a fixation deviceover the guide wire to fix the biceps tendon to the humerus.

Still other embodiments of the invention may include a method of tissuerepair that includes creating a hole in a bone of a first diameter;pushing a portion of soft tissue into the hole with an instrument thatcaptures the soft tissue in a channel adjacent to one or more prongs ofa tip at a distal end of the instrument; inserting a distal portion of aguide wire though the soft tissue and in the hole in the bone; andinserting a fixation device over the guide wire to fix the soft tissueto the bone.

Embodiments of the invention may be directed to an instrument with aproximal end and a distal end, the instrument configured to manipulatesoft tissue during a soft tissue repair procedure. The instrument mayinclude a cannulated instrument body and a first prong coupled to thecannulated instrument body, wherein the first prong is the most distalelement of the instrument and is offset from the cross-sectional centerof the cannulated instrument body. The instrument may also includemarkings on the instrument representing a measured distance from adistal end of the first prong to the markings.

Other embodiments of the invention include an instrument with a proximalend and a distal end, the instrument configured to manipulate softtissue during a soft tissue repair procedure. The instrument may includea cannulated instrument body, a first prong coupled to the cannulatedinstrument body, wherein the first prong is the most distal element ofthe instrument and is offset from the cross-sectional center of thecannulated instrument body, and a second prong coupled to the cannulatedinstrument body opposite from the first prong to form a channel betweenthe first prong and the second prong, wherein the channel aligns atleast in part with a cannulation of the cannulated instrument body. Thefirst prong and the second prong may be rounded and blunted at theirrespective distal ends to not readily penetrate bone when pushed againstthe bone.

Yet other embodiments includes an instrument with a proximal end and adistal end, the instrument configured to manipulate soft tissue during asoft tissue repair procedure. The instrument may have a cannulatedinstrument body, a fork means at a distal end of the instrument forcapturing soft tissue between a first prong of the fork and a secondprong of the fork and aligning the soft tissue with a cannulation of thecannulated instrument body, and a depth determining means for measuringa distance from a distal end of the fork means to markings on theinstrument.

Further areas of applicability of the present disclosure will becomeapparent from the detailed description provided hereinafter. It shouldbe understood that the detailed description and specific examples, whileindicating the preferred embodiment of the disclosure, are intended forpurposes of illustration only and are not intended to limit the scope ofthe disclosure.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings, which are incorporated in and form a part ofthe specification, illustrate the embodiments of the present disclosureand together with the written description serve to explain theprinciples, characteristics, and features of the disclosure. In thedrawings:

FIG. 1 shows a side view of the soft tissue manipulator instrument ofthe present disclosure.

FIG. 1A shows an expanded view of the distal portion of the shaft of theinstrument of FIG. 1.

FIG. 2 shows a cross-sectional view of the instrument of FIG. 1.

FIGS. 3A-3C each show isometric views of the tip of the instrument ofFIG. 1.

FIG. 4A shows a side view of the guide assembly of the presentdisclosure.

FIG. 4B shows a cross-sectional view of the guide assembly of FIG. 4A.

FIG. 5A shows a side view of the soft tissue manipulator assembly of thepresent disclosure.

FIG. 5B shows a cross-sectional view of the soft tissue manipulatorassembly of FIG. 5A.

FIGS. 6-6A show the soft tissue manipulator instrument of FIG. 1 and adrill bit disposed within the instrument prior to creation of a hole inbone.

FIGS. 7-7A show the use of a reamer to increase the diameter of the holecreated by the drill bit of FIGS. 6-6A.

FIG. 8 shows the insertion of the soft tissue manipulator assembly ofFIG. 5A in bone.

FIG. 8A shows a representation of area 100 of FIG. 8 with soft tissue(not shown in FIG. 8) having been inserted into the bone via the softtissue manipulator assembly of FIG. 5A.

FIG. 9 shows disposal of the guide wire of the guide assembly of FIG. 4Awithin bone.

FIG. 9A shows a representation of area 200 of FIG. 9 with soft tissue(not shown in FIG. 9).

FIG. 10 shows insertion of a fixation device into bone via use of adriver.

FIG. 10A shows a representation of area 300 of FIG. 10 with soft tissue(not shown in FIG. 10).

FIG. 11 shows disposal of the guide wire of the guide assembly of FIG.4A and the fixation device of FIGS. 10-10A within bone.

FIG. 11A shows a representation of area 400 of FIG. 11 with soft tissue(not shown in FIG. 11).

FIG. 12 shows disposal of the fixation device of FIGS. 10-10A withinbone.

FIG. 12A shows a representation of area 500 of FIG. 12 with soft tissue(not shown in FIG. 12.

DETAILED DESCRIPTION OF THE EMBODIMENTS

The following description of the preferred embodiment(s) is merelyexemplary in nature and is in no way intended to limit the disclosure,its application, or uses.

FIGS. 1 and 2 show the soft tissue manipulator instrument 10 of thepresent disclosure. The instrument 10 includes a handle 11 and a shaft12 coupled to the handle 11. The instrument 10 includes a cannulation 14that extends the entire length of the instrument 10. The shaft 12includes a proximal portion 12 a coupled to the handle 11 and a distalportion 12 b. The distal portion 12 b includes a tip 13 having prongs 13a and a channel 13 b located between the prongs 13 b. FIGS. 3A-3C showthree tips 13, all of which have a different outer width W. For thepurposes of this disclosure, the widths W of the tips 13 are 4.5 mm, 5.0mm, and 5.5 mm. However, other widths W may be used. As will bedescribed further below, the choice of which instrument 10 to use willdepend on the diameter of the soft tissue that is being repaired. Inaddition, FIG. 1A shows markings 12 b′, and numbers correlating withthose markings, located at the distal portion 12 b of the shaft 12. Aswill be further described below, the markings 12 b′ are used todetermine the depth of a bone hole during repair.

FIGS. 4A and 4B show the guide assembly 20 of the present disclosure.The assembly 20 includes a guide wire 21 having a proximal portion 21 aand a distal portion 21 b. Coupled to the proximal portion 21 a of theguide wire 21 is a wire vice 22. The vice 22 includes a top portion 22a, a bottom portion 22 b, a channel 22 c that houses the proximalportion 21 a of the guide wire 21, a hole 22 d extending perpendicularto the channel 22 c and having threads on an inner surface 22 d′ of thehole 22 d, and a knob assembly 22 e housed within the hole 22 d. Theassembly 22 e includes a knob 22 f and a pin 22 g coupled to the knob 22f. The pin 22 g includes a proximal portion 22 g′ coupled to the knob 22f and a distal portion 22 g″ having threads that are engaged with thethreads on the inner surface 22 d′ of the hole 22 d. Prior to use of theguide assembly 20 during repair, the proximal portion 21 a of the guidewire 21 is disposed within the channel 22 c of the vice 22 and the knob22 f of the knob assembly 22 e is rotated until the distal portion 22 g″of the pin 22 g abuts the proximal portion 21 a of the guide wire 21,thereby coupling the assembly 22 e to the proximal portion 21 a of theguide wire 21.

FIGS. 5A and 5B show the soft tissue manipulator assembly 30 of thepresent disclosure. As will be further described below, the assembly 30is used to insert tissue into bone.

FIGS. 6-12 show a method of soft tissue repair. FIGS. 6 and 6A show thesoft tissue instrument 10 and a drill bit 40 disposed within thecannulation 14 of the instrument 10. The drill bit 40 includes aproximal portion 41 and a distal portion 42 having threads 43. Theinstrument 10 is used as a guide for placement of the drill bit 40 intobone 50. Once the drill bit 40 is disposed in the instrument 10, asshown in FIG. 6, a drill (not shown) is coupled to the proximal portion41 of the bit 40 and is operated to rotate the bit 40 and advance thebit 40 into the bone 50. For the purposes of this disclosure, the drillbit 40 is 2.4 mm in diameter, but other diameter drill bits may be used.Once the bit 40 is advanced into the bone 50, the instrument 10 isremoved while the drill bit 40 is maintained in bone 50.

As shown in FIGS. 7 and 7A, a cannulated reamer 60 is disposed over thedrill bit 40 and is used to provide the create a hole 51 in the bone 50.The reamer 60 includes a distal portion 61 having threads 61 a and aproximal portion 62. Once the reamer 60 is disposed over the drill bit40, a drill (not shown) is then coupled to the proximal portion 62 andoperated to rotate the reamer 60 and advance the reamer 60 into the bone50, thereby creating the hole 51. For the purposes of this disclosure,the diameter of the reamer 60 is 6-8 mm, however the diameter isdependent on the diameter of the soft tissue that is placed within thehole 50, as will be further described below. Therefore, other diameterreamers may be used. In addition, the distal portion 61 of the reamer 60may include number markings, similar to the markings 12 b′ describedabove, for measuring the depth of the reamer 60 as it is being advancedinto the bone 50.

Once the reamer 60 and the drill bit 40 have been removed from the bone50, the soft tissue manipulator instrument 10 is used to manipulate thesoft tissue 70 and place the soft tissue 70 within the channel 13 b. Theshaft 12 of the instrument 10 and the soft tissue 70 are then placedwithin the hole 51 and the guide assembly 20 is placed within thecannulation 14 of the instrument 10 until the bottom portion 22 b of thevice 22 abuts the handle 11 of the instrument 10, as shown in FIG. 8. Atthe same time, the distal portion 21 b of the wire 21 is insertedthrough the soft tissue 70 and subsequently disposed within the bone 50lying beneath the hole 51, as shown in FIG. 8A. The distal portion 21 bof the wire 21 is inserted into the bone 50 by tapping the top portion22 a of the vice 22 with a mallet, or another striking force, until thebottom portion 22 b abuts the handle 11. The vice 22 acts as a depthstop in limiting the depth of the distal portion 21 b of the wire 21into the bone 50. Other factors that limit the depth of the distalportion 21 b into the bone 50 include, without limitation, the length ofthe wire 21, the length of the instrument 10, and the depth of thechannel 22 a.

FIGS. 9 and 9A show that the vice 22 has been removed from the proximalportion 21 a of the wire 21 by disengaging the pin 22 g from the wire 21and uncoupling the vice 22 from the proximal portion 21 a. Theinstrument 10 has also been removed from the hole 51, thereby leavingthe wire 21 alone in the hole 51.

The wire 21 is subsequently used to guide the insertion of a fixationdevice 80, such as an interference screw, into the hole 51, as shown inFIGS. 10 and 10A. A driver assembly 90, which includes a cannulateddriver 91 having a handle 91 a and a shaft 91 b coupled to the handle 91a and the cannulated fixation device 80 coupled to the shaft 91 b, isdisposed over the wire 21. The driver 91 is rotated to insert the device80 into the hole 51, such that the threaded outer surface 81 of thedevice 80 is engaged with the soft tissue 70, thereby fixating the softtissue 70 to the bone 50. After insertion of the device 80 into the hole51, the driver 91 and the wire 21 are both removed from the bone 50,thereby leaving the device 80 within the hole, as shown in FIGS. 11-11Aand 12-12A. The wire 21 is removed by placing the proximal portion 21 ainto the channel 22 c of the vice 22, rotating the knob 22 f to couplethe assembly 22 e to the wire 21, and then using the assembly 22 e toremove the wire 21 from the hole 50. Other methods of removing the wire21 are also within the scope of this disclosure.

The soft tissue manipulator instrument 10 and drill bit 40 are made froma biocompatible material, such as titanium, stainless steel, or otherbiocompatible material and via a machining process or other processknown to one of skill in the art. A combination of processes may also beused to make the instrument 10 and drill bit 40. The cannulation 14 andchannel 13 b are formed during or after the machining process via amethod, such as drilling. The markings 12 b′ and associated numbers areformed by a laser or another method and the threads 43 are formed via amachining process.

The guide assembly 20 and its components and the reamer 60 are also madefrom a biocompatible material, such as titanium, stainless steel, orother biocompatible material and via a machining process or otherprocess known to one of skill in the art. A combination of processes mayalso be used to make the assembly 20 and reamer 60. The channel 22 c,hole 22 d, cannulation, and threads on the inner surface 22 d′ of thehole 22 d, the distal portion 22 g″ of the pin 22 g, and the reamer 60are formed during or after the machining process via a process, such asdrilling or other process known to one of skill in the art.

The fixation device 80 is made from a resorbable polymer material.However, a metal material and other non-metal materials, eitherresorbable or non-resorbable, are also within the scope of thisdisclosure. In addition, the device 80 may be made via a molding processor other process known to one of skill in the art. The cannulation andthreads on the outer surface 81 of the device 80 may be formed duringthe molding process or after the molding process by drilling ormachining.

As various modifications could be made to the exemplary embodiments, asdescribed above with reference to the corresponding illustrations,without departing from the scope of the disclosure, it is intended thatall matter contained in the foregoing description and shown in theaccompanying drawings shall be interpreted as illustrative rather thanlimiting. Thus, the breadth and scope of the present disclosure shouldnot be limited by any of the above-described exemplary embodiments, butshould be defined only in accordance with the following claims appendedhereto and their equivalents.

What is claimed is:
 1. An instrument with a proximal end and a distalend, the instrument configured to manipulate soft tissue during a softtissue repair procedure, the instrument comprising: a cannulatedinstrument body; a first prong coupled to the cannulated instrumentbody, wherein the first prong is a most distal element of the instrumentand is offset from a cross-sectional center of the cannulated instrumentbody; and markings on the instrument representing a measured distancefrom a distal end of the first prong to the markings.
 2. The instrumentof claim 1 wherein the cannulated instrument body includes a handle atits proximal end.
 3. The instrument of claim 1 wherein the cannulatedinstrument body includes a shaft near its distal end.
 4. The instrumentof claim 1, further comprising a second prong coupled to the cannulatedinstrument body opposite from the first prong to form a channel betweenthe first prong and the second prong, wherein the channel aligns atleast in part with a cannulation of the cannulated instrument body. 5.The instrument of claim 4 wherein the second prong is substantially amirror image of the first prong about a longitudinal axis of thecannulated instrument body.
 6. The instrument of claim 4 wherein adiameter of the prongs is larger than a diameter of the instrumentproximal of the prongs.
 7. The instrument of claim 4 wherein there aremarkings on the instrument representing a measured distance from adistal end of the second prong to the markings.
 8. The instrument ofclaim 4 wherein the first and second prongs have respective first axesparallel with a longitudinal axis of the cannulated instrument body, andthe first and second prongs are generally rectangular in cross-sectiontransverse to their respective first axes, and each of the first andsecond prongs has a longer length side of its respective rectangularcross-section that is oriented generally perpendicularly to thelongitudinal axis of the cannulated instrument body.
 9. An instrumentwith a proximal end and a distal end, the instrument configured tomanipulate soft tissue during a soft tissue repair procedure, theinstrument comprising: a cannulated instrument body; a first prongcoupled to the cannulated instrument body, wherein the first prong is amost distal element of the instrument and is offset from across-sectional center of the cannulated instrument body; a second prongcoupled to the cannulated instrument body opposite from the first prongto form a channel between the first prong and the second prong, whereinthe channel aligns at least in part with a cannulation of the cannulatedinstrument body; and markings on the instrument representing a measureddistance from a distal end of the first prong to the markings; whereinthe first prong and the second prong are rounded and blunted at theirrespective distal ends to not readily penetrate bone when pushed againstthe bone.
 10. The instrument of claim 9 wherein the cannulatedinstrument body includes a handle at its proximal end.
 11. Theinstrument of claim 9 wherein the cannulated instrument body includes ashaft near its distal end.
 12. The instrument of claim 11 wherein adiameter of the prongs is larger than a diameter of the shaft proximalof the prongs.
 13. The instrument of claim 9 wherein the second prong issubstantially a mirror image of the first prong about a longitudinalaxis of the cannulated instrument body.
 14. An instrument with aproximal end and a distal end, the instrument configured to manipulatesoft tissue during a soft tissue repair procedure, the instrumentcomprising: a cannulated instrument body; a fork means at a distal endof the instrument for capturing soft tissue between a first prong of thefork and a second prong of the fork and aligning the soft tissue with acannulation of the cannulated instrument body; and a depth determiningmeans for measuring a distance from a distal end of the fork means tomarkings on the instrument.
 15. The instrument of claim 14 wherein thecannulated instrument body includes a handle at its proximal end. 16.The instrument of claim 14 wherein the cannulated instrument bodyincludes a shaft near its distal end.
 17. The instrument of claim 16wherein an outer diameter of the fork means is larger than the shaftproximal of the fork means.
 18. The instrument of claim 14 wherein achannel is formed between the first prong of the fork and the secondprong of the fork and the channel is substantially coaxially alignedwith the cannulation of the cannulated instrument body.
 19. Aninstrument with a proximal end and a distal end, the instrumentconfigured to manipulate soft tissue during a soft tissue repairprocedure, the instrument comprising: a cannulated instrument body; afirst prong coupled to the cannulated instrument body, wherein the firstprong is a most distal element of the instrument and is offset from across-sectional center of the cannulated instrument body; a second prongcoupled to the cannulated instrument body opposite from the first prongto form a channel between the first prong and the second prong, whereinthe channel aligns at least in part with a cannulation of the cannulatedinstrument body; and markings on the instrument representing a measureddistance from a distal end of the second prong to the markings; whereinthe first prong and the second prong are rounded and blunted at theirrespective distal ends to not readily penetrate bone when pushed againstthe bone.
 20. The instrument of claim 19 wherein the cannulatedinstrument body includes a handle at its proximal end.
 21. Theinstrument of claim 19 wherein the cannulated instrument body includes ashaft near its distal end.
 22. The instrument of claim 21 wherein adiameter of the prongs is larger than a diameter of the shaft proximalof the prongs.
 23. The instrument of claim 19 wherein the second prongis substantially a mirror image of the first prong about a longitudinalaxis of the cannulated instrument body.